British drug maker GlaxoSmithKline and Valeant Pharmaceuticals International said Wednesday that a panel of 13 federal health experts unanimously agreed there is “substantial evidence” the potential epilepsy treatment ezogabine is an effective adjunctive treatment for adults with partial-onset seizures.
Ezogabine is designed for patients already taking one to three other anti-epileptic drugs. Partial-onset seizures, which are triggered by epilepsy, start in one side of the brain but can spread through the whole brain.
The Food and Drug Administration advisory committee also voted that a side effect of urinary retention could be mitigated by patient monitoring.
Susan Hall, Valeant’s head of neurology research, said in a statement there is a significant need for additional anti-epileptic drugs because about a third of patients continue to experience seizures despite treatment.
The drug is being jointly developed by GlaxoSmithKline and Valeant, which is based in Aliso Viejo, Calif.
The FDA is scheduled to complete its review of the drug by Aug. 30. It is not required to follow the advice of its panelists, though it usually does.
Shares of Valeant rose 10 cents to $57.97 Wednesday in aftermarket trading, while U.S.-traded shares of GlaxoSmithKline were up 9 cents to $36.55.
The Associated Press